NATIONAL REGISTRIES OF RARE DISEASES IN EUROPE: AN OVERVIEW BY THE EPIRARE PROJECT.
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1 D. Taruscio and L. Vittozzi National Centre for Rare Diseases National Institute of Health Rome, Italy NATIONAL REGISTRIES OF RARE DISEASES IN EUROPE: AN OVERVIEW BY THE EPIRARE PROJECT. ICORD 2014, Ede (NL), 7-9 October, 2014
2 The RD Registries in EU More than 600 rare disease registries (Orphanet and other sources) No uniform standards for the storing and management of data Registries set up for a small fraction of rare diseases, multiple registries for the same disease Need to increase data comparability and sharing Need to harmonise existing regulations (EU, national and regional)
3 The EU initiatives COUNCIL RECOMMENDATION on an action in the field of rare diseases (2009): Recommends that Member States support at all appropriate levels, for epidemiological purposes, registries and databases Funding priorities include RD registries and disease networks EPIRARE EU Platform for RD registries (Building Consensus and Synergies for EU Registration of RD patients) RD-Connect PARENT ERNs Other disease-specific projects EU Platform for the Registration of RD patients (JRC, Ispra)
4 The European RDR Platform objectives To Increase sustainability To improve data comparability, by means : Reference set of Common Data Elements Reference coding and catalogues Reference data quality assurance procedures Provision of useful tools
5 The opportunity offered by National (institutional) registries Improved epidemiological information on RD, by means of: Integration of multiple national sources Mortality/Population Registry E-prescription Electronic Health Records Increased completeness of case ascertainment E.g.: designation of CoE linked to case notification and follow-up E.g.: Mandatory registration of patients E.g.: Registration linked to prescriptions Appropriate management of data protection rules E.g.: Legal basis of data collection E.g.: Appropriate procedures for data protection
6 National (institutional) RD Registries Running: Italy (2001) France (2005; 2007) Spain (2008) Belgium (2013) Nordic Countries (Denmark, Finland, Norway and Sweden): craniofacial diseases, being expanded to all very rare diseases Finland (a general disease registry, including RD) Under planning: Bulgaria Germany (very rare and undiagnosed diseases) Sweden
7
8 National Registries (NR) operation Country Belgium, France, Italy Spain Legal basis The NR activity is part of the mandatory activities of the healthcare network of centres dedicated to RD. The NR is funded as a research project, with the Involvement of institutional, scientific, patient, and industry stakeholders. Country Belgium,Italy, Spain France Patient coding Univocal, but not common, patient coding system De-identification
9 National Registries (NR) operation Country Scope Aims Belgium France Italy Spain All diagnosed RD surveillance, public health planning patient recruitment, clinical research +patient recruitment, source integration (EHR) +clinical research (not supported yet) +patient recruitment, translational research, social policies
10 National Registries (NR) operation Country Belgium France Italy Spain Common Data Elements (central repository) Patient ID code and demographic data, death date, registering centre and treating physicians codes; first symptom onset date, diagnosis and its features, and different options of patient consent. Patient ID code and demographic data, patient consent, familiarity of the disease, death date and cause, drug treatment, services data, diagnosis and its features, fetus and newborn data, data on research participation and biological sample donations. patient ID code and demographic data, live or dead status and death date, diagnosis, diagnosis date, diagnosis centre data, first symptom onset date, prescribed orphan drug, cost exemption code Temporarily: patient ID code, demographic data, diagnosis.
11 National Registries: hurdles or opportunities? National Registries are developing independently from each other. Different CDEs Different patient univocal coding systems Partially overlapping aims Possibly different indicators
12 The Italian Network for the Registration of RD patients NATIONAL REGISTRY FOR RARE DISEASES Minimum Data Set Regional Registry of RD - Interregional Reference Centre Trusted Centres in a given region
13 Rare Diseases in NRRD (2013) grouped by ICD-9 Chapters (N = records) records % Diseases of the Central Nervous System and Sense Organs Congenital Anomalies ,7 Endocrine, Nutritional, Metabolic Diseases, and Immunity Disorders ,4 Diseases of the Blood and Blood-Forming Organs ,6 Diseases of the Musculoskeletal System and Connective Tissue ,5 Neoplasms Diseases of the Circulatory System ,3 Diseases of the Skin and Subcutaneous Tissue ,3 Diseases of the Digestive System ,3 Diseases of the Genitourinary System 627 0,6 Infectious and Parasitic Diseases 144 0,1 Certain Conditions Originating in the Perinatal Period 108 0,1 Symptoms, Signs, and Ill-Defined Conditions 3 0
14 Thank you for your attention! DomenicaTaruscio
15 The Spanish RDR From Manuel Posada, presented at the EPIRARE Workshop on National Rare Diseases Registries. Rome, 5 March 2014
16 The Spanish RDR From Manuel Posada, presented at the EPIRARE Workshop on National Rare Diseases Registries. Rome, 5 March 2014
17 The Spanish RDR From Manuel Posada, presented at the EPIRARE Workshop on National Rare Diseases Registries. Rome, 5 March 2014
18 The French network From Paul Landais, presented at the EPIRARE Workshop on National Rare Diseases Registries. Rome, 5 March 2014
19 The French network From Paul Landais, presented at the EPIRARE Workshop on National Rare Diseases Registries. Rome, 5 March 2014
20 The Ra.Di.Co. section From Paul Landais, presented at the EPIRARE Workshop on National Rare Diseases Registries. Rome, 5 March 2014
21 The Ba.Ma.Ra. section From Paul Landais, presented at the EPIRARE Workshop on National Rare Diseases Registries. Rome, 5 March 2014
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